Does non-evidence-based ICD implantation increase in-hospital mortality and complications compared to evidence-based ICD implantation in patients receiving primary prevention ICDs?
Nearly one-quarter of primary prevention ICD implants in the US do not meet evidence-based criteria and are associated with significantly higher in-hospital mortality and complications.
CONTEXT: Practice guidelines do not recommend use of an implantable cardioverter-defibrillator (ICD) for primary prevention in patients recovering from a myocardial infarction or coronary artery bypass graft surgery and those with severe heart failure symptoms or a recent diagnosis of heart failure. OBJECTIVE: To determine the number, characteristics, and in-hospital outcomes of patients who receive a non-evidence-based ICD and examine the distribution of these implants by site, physician specialty, and year of procedure. DESIGN, SETTING, AND PATIENTS: Retrospective cohort study of cases submitted to the National Cardiovascular Data Registry-ICD Registry between January 1, 2006, and June 30, 2009. MAIN OUTCOME MEASURE: In-hospital outcomes. RESULTS: Of 111, 707 patients, 25, 145 received non-evidence-based ICD implants (22. 5%). Patients who received a non-evidence-based ICD compared with those who received an evidence-based ICD had a significantly higher risk of in-hospital death (0. 57% 95% confidence interval CI, 0. 48%-0. 66% vs 0. 18% 95% CI, 0. 15%-0. 20%; P <. 001) and any postprocedure complication (3. 23% 95% CI, 3. 01%-3. 45% vs 2. 41% 95% CI, 2. 31%-2. 51%; P <. 001). There was substantial variation in non-evidence-based ICDs by site. The rate of non-evidence-based ICD implants was significantly lower for electrophysiologists (20. 8%; 95% CI, 20. 5%-21. 1%) than nonelectrophysiologists (24. 8% 95% CI, 24. 2%-25. 3% for nonelectrophysiologist cardiologists; 36. 1% 95% CI, 34. 3%-38. 0% for thoracic surgeons; and 24. 9% 95% CI, 23. 8%-25. 9% for other specialties) (P<. 001 for all comparisons). There was no clear decrease in the rate of non-evidence-based ICDs over time (24. 5% 6908/28, 233 in 2006, 21. 8% 7395/33, 965 in 2007, 22. 0% 7245/32, 960 in 2008, and 21. 7% 3597/16, 549 in 2009; P <. 001 for trend from 2006-2009 and P =. 94 for trend from 2007-2009). CONCLUSION: Among patients with ICD implants in this registry, 22. 5% did not meet evidence-based criteria for implantation.
Sana M. Al‐Khatib (2011) studied this question.